EHE · Dispenser, Mercury And/Or Alloy
Dental · 21 CFR 872.3080 · Class 1
Overview
| Product Code | EHE |
|---|---|
| Device Name | Dispenser, Mercury And/Or Alloy |
| Regulation | 21 CFR 872.3080 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771749 | AMALGAM DISPENSER | New Dimensions IN Medicine, Inc. | Sep 28, 1977 | SESE |
| K771396 | DISPENSER, MERCURY & TABLET/POWDER | Johnson & Johnson Professionals, Inc. | Aug 3, 1977 | SESE |
Top Applicants
- New Dimensions IN Medicine, Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
